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Could a bladder pill cool down breast cancer hot flashes?

NCT ID NCT01530373

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two drugs—solifenacin (used for overactive bladder) and clonidine (a common hot flash treatment)—to see which better reduces hot flashes in breast cancer patients on hormone therapy. About 110 women will take one of the pills daily for three weeks and track their symptoms. The goal is to find a more effective way to ease this common side effect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
solifenacin (Vesicare) and clonidine (Catapres, Dixarit)
What this could lead to
If solifenacin works better than clonidine, it could offer a new option for managing hot flashes in breast cancer survivors.
What could go wrong
This is a small, early-phase study with only 110 participants. The drug may not prove more effective than clonidine, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Feb 2012

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women with a history of invasive breast cancer or DCIS * Currently taking aromatase inhibitors or tamoxifen * Not receiving hormone replacement therapy for minimum of one month * Age 18 years or older * Self-reported hot flashes at least fourteen times per week * Self-reported hot flashes for at least one month * If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks. Exclusion Criteria: * Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin. * Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible) * History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record * Concurrent or planned chemotherapy or radiotherapy (within next 3 months) * Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide. * Currently using CYP3A4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent CYP3A4 inhibitors (i.e., chloramphenicol, clarithromycin, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazoldone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin). * Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \& physical exam and medical record) * Hypotension or uncontrolled hypertension (160/95 \> BP \< 100/60) * Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history \& physical and medical record) * History of allergy or adverse reactions to clonidine or solifenacin * ECOG status \> 2 (in bed more than 50% of day)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 722205, United States

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